Evidence map›Paper›PMID 27663070›Full record

Trial reportAmerican journal of ophthalmology2016

Gevokizumab in the Treatment of Autoimmune Non-necrotizing Anterior Scleritis: Results of a Phase I/II Clinical Trial.

Jared E Knickelbein, William R Tucker, Nirali Bhatt, Karen Armbrust, David Valent, Dominic Obiyor, Robert B Nussenblatt, H Nida Sen

Registry-linked trialAbstract readClinical Trial
In one paragraph

Trial report in American journal of ophthalmology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01835132 (Gevokizumab Treatment for Active Scleritis By IL-1 Inhibition), which is not on this map. Cited by 14 papers.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed
3.3field-weighted citation impact, top 8% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01835132 phase1 / phase2completednot on this map

Gevokizumab Treatment for Active Scleritis By IL-1 Inhibition (GATSBY)

TypeinterventionalSponsorNational Eye Institute (NEI)Ran2013 to 2016Enrolled8ConditionsScleritisArmsGevokizumab
3 · Its place in the literature

Who cites it

14 citing papers in PubMed, 32 citations in OpenAlex.

  1. Review
  2. Update on Therapy for Non-Infectious Scleritis.Clinical ophthalmology (Auckland, N.Z.) · 2026
    Review
  3. Review
  4. Article
  5. Article
  6. Review
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  9. Article
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  13. Observational
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors at 2 institutions in 1 country.

Jared E KnickelbeinNational Eye Institute, National Institutes of Health, Bethesda, Maryland.
William R TuckerNational Eye Institute, National Institutes of Health, Bethesda, Maryland.
Nirali BhattNational Eye Institute, National Institutes of Health, Bethesda, Maryland.
Karen ArmbrustNational Eye Institute, National Institutes of Health, Bethesda, Maryland.
David ValentNational Eye Institute, National Institutes of Health, Bethesda, Maryland.
Dominic ObiyorNational Eye Institute, National Institutes of Health, Bethesda, Maryland.
Robert B NussenblattNational Eye Institute, National Institutes of Health, Bethesda, Maryland.
H Nida SenNational Eye Institute, National Institutes of Health, Bethesda, Maryland. Electronic address: senh@nei.nih.gov.
National Institutes of Health · USNational Eye Institute · US

Funding

Studies of Ocular inflammation: Clinical researchZIAEY000557 · NEI · NATIONAL EYE INSTITUTE · PI SEN, HATICE · 2017 to 2018
$2.0M
Gevokizumab Treatment for Active Scleritis By IL-1 Inhibition (GATSBY)ZIAEY000538 · NEI · NATIONAL EYE INSTITUTE · PI SEN, HATICE · 2014 to 2016
$345k
Intramural NIH HHS Z99 EY999999Intramural NIH HHS ZIA EY000538
6 · The paper itself

Abstract

purposeTo evaluate the safety and potential efficacy of gevokizumab, an anti-interleukin 1β (IL-1β) monoclonal antibody, in the treatment of active, noninfectious, non-necrotizing anterior scleritis.

designPhase 1/2, open label, nonrandomized, prospective, single-arm pilot trial.

methodsEight patients with active, noninfectious, non-necrotizing anterior scleritis with a scleral inflammatory grade of +1 to +3 in at least 1 eye were enrolled. In 1 patient both eyes were enrolled, for a total of 9 eyes (4 eyes with +1, 1 eye with +2, and 4 eyes with +3). Patients received 1 subcutaneous injection of 60 mg gevokizumab at baseline and then every 4 weeks for 12 weeks. Complete physical and ocular examinations were performed at each visit. The primary outcome was at least a 2-step reduction or reduction to grade 0 in scleral inflammation on a 0 to +4 scale according to a standardized photographic scleritis grading system by 16 weeks in the study eye compared to baseline. Secondary outcomes included changes in visual acuity, intraocular pressure, and trends in scleral grading. Participants who met the primary outcome were eligible to continue in the study for up to 52 weeks and received additional gevokizumab injections every 4 weeks until week 36, followed by 2 safety visits at weeks 40 and 52.

resultsSeven eyes from 7 patients met the primary outcome within a median time of 2 weeks following the first gevokizumab injection. No definitive changes in visual acuity or intraocular pressure were identified. There were no serious adverse events related to the study drug. A total of 43 adverse effects were reported, with 93% described as mild, 95% as nonocular, and only 14% deemed possibly caused by the investigational treatment.

conclusionsThe results of this small study suggest that blockage of IL-1β using gevokizumab may be beneficial in treating active, noninfectious anterior scleritis and that gevokizumab is well tolerated. Larger randomized trials are warranted to assess the true efficacy of gevokizumab in the treatment of non-necrotizing anterior scleritis.

Indexed as

AutoimmunityVisual AcuityAdultAgedAged, 80 and overAnterior Eye SegmentAntibodies, Monoclonal, HumanizedAutoimmune DiseasesDose-Response Relationship, DrugDrug Administration ScheduleFemaleFollow-Up StudiesHumansInjections, SubcutaneousMaleMiddle AgedAntibodies, Monoclonal, Humanizedgevokizumab

Identifiers

PMID27663070
PMCPMC5121021
OpenAlexW2521428759

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.